FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D
MDR report key: 3220149
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04609
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 9, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN-CLINIC FOR ROUTINE FOLLOW-UP, NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T-WAVE OVERSENSING WAS OBSERVED. THE PATIENT DID NOT RECEIVE INAPPROPRIATE THERAPY. THE OVERSENSING WAS NOTED ON A STORED EGM. IT WAS RECOMMENDED TO REPROGRAM THE DEVICE.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED STATES THAT PATIENT PRESENTED IN CLINIC FOR FOLLOW UP WHEN FURTHER EPISODES OF POST-PACED T WAVE OVERSENSING WERE OBSERVED. THE DEVICE WAS REPROGRAMMED. THERE WERE NO ADVERSE EVENTS FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321066 | QUADRA ASSURA CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3265-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |